510(k) K922136 ยท CGA Glucose Oxidase, Glucose
ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP
| Applicant | Home Diagnostics, Inc., Eatontown NJ, US |
| Decision | Substantially Equivalent, Aug 10, 1993 |
| Received | Apr 22, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922136
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.